A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181
Recruiting
Phase 1Interventional Study
Advanced Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
Who this trial is looking for
This trial is looking for people with advanced solid tumors who haven't had success with standard treatments. Participants will receive a new treatment called Hemay181 and will be monitored for its effects and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have advanced solid tumors that have not responded to standard treatments.
I have at least one measurable tumor that can be assessed by imaging.
It has been at least 4 weeks since my last treatment or I have fully recovered from my last treatment.
I have an ECOG performance status score of 0-1.
I expect to live more than 3 months.
I have signed a written consent form.
I am a woman of childbearing potential and use effective contraception.
You may not be able to join if
I am pregnant or breastfeeding.
I have tested positive for HIV or syphilis.
I have hepatitis B or C that exceeds normal levels.
I have received treatment from another clinical trial in the last 4 weeks.
I am allergic to the study drug or its ingredients.
I have a history of severe mental illness or substance abuse.
The study doctor believes I am not suitable for this trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subjects who voluntarily signed a written informed consent form before the start of the study;
2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no a…
Inclusion Criteria:
1. Subjects who voluntarily signed a written informed consent form before the start of the study;
2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
3. Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\].
5. Subjects with ECOG PS score of 0-1;
6. Subjects with expected survival more than 3 months;
7. Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study;
Exclusion Criteria:
1. Women during pregnancy or breastfeeding;
2. HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;
3. Having received drug treatment from another clinical trial within the four weeks prior to enrolment;
4. Aallergy to the active ingredient or excipients of the investigational medicinal product;
5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
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